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NCT Number: NCT06737640

Evaluation of Clinical and Molecular Biomarkers in Immunotherapy Treatment in Gynecologic Cancer

Background: Immunotherapy has changed the therapeutic approach for gynecologic gynecological malignancies such us endometrial and cervical cancer. Despite literature data support the strong effect of immunotherapy in these cancers, a share of patients do not respond to immunotherapy. Furthermore the extremely variable immune-related spectrum of toxicity in terms of events and timing makes it necessary to identify predictive factors for the development of these side effects.

Hyphotesis: To evaluate the presence of biochemical, bioumoral and or molecular predictive factors in patients affected by endometrial and cervical cancer treated with immunotherapy plus chemotherapy, immunotherapy plus tyrosine kinase inhibitors (TKI) or immunotherapy alone.

Methodology: We will retrospectively collect data about patients affected by advanced, recurrent or metastatic endometrial cancer (EC) and recurrent cervical cancer (CC) treated with immunotherapy.

We will investigate whether there is a statistically significant difference in the efficacy of immunotherapy according to biochemical, biohumoral and or molecular factors and survival outcomes. Moreover, we will evaluate whether there is a correlation between biochemical, biohumoral and or molecular factors and immune-related adverse events (irAE).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, UOC Ginecologia Oncologica

Rome, Lazio, 000168, Italy

Location contact

Claudia Marchetti, Prof.

SUB_INVESTIGATOR

Eleonora Palluzzi, MD

CONTACT

[email protected]

Eleonora Palluzzi, MD

PRINCIPAL_INVESTIGATOR

Francesco Fanfani, Prof.

SUB_INVESTIGATOR

Giovanni Scambia, Prof.

SUB_INVESTIGATOR

Maria Gabriella Ferrandina, Prof.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females aged ≥ 18 years at the time of inclusion in the study.
  • Patients diagnosed with advanced, metastatic or recurrent endometrial and cervical cancer treated at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
  • Patients with histological confirmation of endometrial and cervical cancer, according to the histotypes suitable for immunotherapy.
  • Patients previously treated under Nominal Use and/or Expanded Access Program (EAP) programs can be enrolled in the study.
  • Patients who have received at least 1 dose of immunotherapy after starting treatment.
  • Signature of the informed consent or declaration in lieu of the consent form where applicable

Exclusion criteria

  • Use of immunotherapy within an experimental protocol.
  • Patients who continued therapy at another center.

Treatment and study plan

Primary outcomes

  1. Evaluation of biomarkers in immunotherapy in endometrial cancer.

    Time frame: 12 months

    Evaluate the association between biochemical, biohumoral and molecular factors and survival outcome in patients with advanced, metastatic or recurrent endometrial cancer treated with immunotherapy and chemotherapy, immunotherapy and tyrosine kinase inhibitors or immunotherapy in monotherapy.

  2. Evaluation of biomarkers in immunotherapy in cervical cancer.

    Time frame: 12 months

    Evaluate the association between biochemical, biohumoral and molecular factors and survival outcome in patients with advanced, metastatic or recurrent cervical cancer treated with immunotherapy and chemotherapy, immunotherapy and tyrosine kinase inhibitors or immunotherapy in monotherapy.

Secondary outcomes

  1. Evaluation of immuno-related adverse events (irAEs) in gynecologic cancer.

    Time frame: 12 months

    Evaluate the association between biochemical, biohumoral and possibly molecular factors and the onset of immune-related adverse events during and after the end of immunotherapy treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Eleonora Palluzzi, MD

CONTACT

[email protected]

+390630156540

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Evaluation of Biochimical, Bioumoral and Molecular Features as Predicitive Factors of Response or Toxicities During Immunotherapy Treatment of Uterine Cancer Patients

Acronym: Immuno-Gyn

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 17, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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